Job OpportunitySupport the evaluation, qualification, and documentation of computerized systems and manufacturing processes. This role is ideal for a detail-oriented professional with experience in FDA-regulated environments and strong bilingual communication skills.
Responsibilities may include the following and other duties may be assigned:Evaluate the impact of validated computerized systems on existing work instructions and processes.Prepare and execute computer system validation protocols and generate comprehensive reports.Develop and maintain Installation Qualification (IQ) documentation.Collaborate with process owners to implement changes to work instructions and ensure compliance.Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.Ensure adherence to company procedures, quality system regulations, and industry standards.Apply technical expertise and knowledge of Medtronic's engineering practices to optimize equipment and manufacturing techniques.Organize and track project progress, maintaining detailed documentation and status updates.Contribute to cross-functional projects and support milestone completion.Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.Requirements:Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experiencePractical knowledge and demonstrated competence in validation and quality systemsBachelor's degree in EngineeringTop 3 Qualifications:Hands-on experience in Process and Computerized Systems ValidationBackground in FDA-regulated industries (e.g., medical devices, pharmaceuticals, biotech)Excellent verbal and written communication skills in both English and Spanish*Willing to work 100% On-Site in Villalba.